Evaluation Of Celecoxib In Combination With Weekly Docetaxel In Elderly (70 Years) Or Poor Performance Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
- Determine the efficacy and feasibility of celecoxib combined with docetaxel as
first-line therapy in elderly or poor performance status patients with advanced
non-small cell lung cancer.
- Determine the response rate of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral celecoxib twice daily (beginning on day -7 of the first course) and
docetaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days in the
absence of disease progression or unacceptable toxicity. Patients who achieve a complete
response (CR) receive 2 additional courses after CR. Patients who achieve stable disease
(SD) or a partial response (PR) receive a minimum of 2 additional courses after SD or PR. At
the discretion of the treating physician, patients then receive maintenance therapy
comprising celecoxib only.
Patients who discontinue therapy for disease progression or unacceptable toxicity are
followed for at least 6 months.
PROJECTED ACCRUAL: A total of 21-39 patients will be accrued for this study within 13-28
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Efficacy of combining celecoxib with docetaxel in elderly (> or = 70 yrs old) or poor performance status (PS)of 2
Blood levels of VEGF & PGE2
Weeks 1, 2, and 3
Shirish M. Gadgeel, MD
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|